Factors predictive of treatment-emergent adverse events of prucalopride: an integrated analysis of four randomized, double-blind, placebo-controlled trials

• Published in: Gut and liver Vol. 9; no. 2; pp. 208 - 213
• Main Authors: Leelakusolvong, Somchai, Ke, MeiYun, Zou, Duowu, Choi, Suck Chei, Tack, Jan, Quigley, Eamonn M M, Liu, Andy, Kim, Jin Yong
• Format: Journal Article
• Language: English
• Published: Korea (South) Gut and Liver 01.03.2015; Gastroenterology Council for Gut and Liver; 거트앤리버 소화기연관학회협의회
• Subjects: Abdominal Pain - chemically induced; Adult; adverse events; Aged; Aged, 80 and over; Asian Continental Ancestry Group - statistics & numerical data; Benzofurans - adverse effects; chronic constipation; Clinical Trials, Phase III as Topic; Constipation - drug therapy; Constipation - ethnology; Diarrhea - chemically induced; Double-Blind Method; Female; Headache - chemically induced; Humans; Male; Middle Aged; Multicenter Studies as Topic; Nausea - chemically induced; Original; predictors; prucalopride; Randomized Controlled Trials as Topic; Regression Analysis; 내과학; Chronic constipation; Prucalopride; Adverse events; Predictors
• ISSN: 1976-2283; 2005-1212
• DOI: 10.5009/gnl14290

This integrated analysis aimed to identify the factors associated with the most frequently re-ported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on pa-tients treated with prucalopride 2 mg or placebo were ana-lyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly as-sociated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differ-ences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to expe-rience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. Con-clusions Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians. (Gut Liver, 2015;9208-213).